A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age

Meningitis Clinical Trial

Official title:

An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological Age

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01366651
• Other study ID #: CR016189
• Secondary ID: DORIPED10022011-
• Status: Terminated
• Phase: Phase 1
• First received: April 14, 2011
• Last updated: December 4, 2013
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: December 2013
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the penetration of doripenem in the cerebral spinal fluid in pediatric patients <1 year of age who are hospitalized and have a documented or suspected infection and are planning to, or undergoing treatment with intravenous (IV) antibiotics.

Description:

This is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) study to characterize the penetration of doripenem in the cerebral spinal fluid (CSF) in pediatric patients <1 year of age who are hospitalized but medically stable, and who have a documented or suspected infection and are planning to, or undergoing treatment with antibiotics administered intravenously (in a vein, abbreviated as "IV"). Doripenem will not replace the patients' prescribed antibiotic(s). The study includes 3 phases: a pretreatment phase consisting of an up to 24-hour screening period; a 2-day open-label treatment period when doripenem will be administered, and CSF and blood samples will be collected, and a follow-up visit approximately 1 week after administration of the last dose of doripenem. The total duration of the study is approximately 10 days. During the study, patients <12 weeks of age will receive a 10 mg/kg doripenem 1-hour IV infusion via a central or peripheral venous line (a catheter inserted in a large vein) every 8 hours; patients 12 weeks to <1 year of age will receive a 30 mg/kg doripenem 1-hour IV infusion every 8 hours. A total of 5 doses of doripenem will be administered over a 2-day period while the patient is in the hospital.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Patient is expected to require hospitalization for the entire open-label phase of the study.

• Patient must be scheduled to have cerebral spinal fluid obtained via a lumbar puncture (referred to as a "spinal tap") or ventriculoperitoneal (VP) shunt tap within 3 days of enrollment into this study.

• Patient must have documented or suspected infection and is planning to, or undergoing treatment with IV antibiotics.

• Parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study.

Exclusion Criteria:

• Clinically significant abnormal values for hematology or clinical chemistry at screening that, at the option of the investigator, are not consistent with the patient's underlying disease(s) or therapies.

• Any condition at screening that, in the opinion of the investigator, may interfere with the assessments of this study.

• Patients with substantially compromised renal (kidney) function: e.g., urine output is <0.25cc/kg/hr within the 24 hours before screening.

• History of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other Beta-lactam antibiotics.

• Known allergy to heparin or history of heparin-induced thrombocytopenia, if an in-dwelling cannula (e.g., heparin lock) or central line is used.

• Patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration.

• Patients concomitantly treated with probenecid or valproic acid (VPA).

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Meningitis

Intervention

Drug:
• Doripenem
Type=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age.
• Doripenem
Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Doripenem concentrations in CSF and plasma		For up to 2 days	No
Secondary	Number of patients with adverse events		Up to Day 9	No
Secondary	Changes in clinical laboratory test results		From Day -1 to Day 9	No
Secondary	Changes in physical examination results reported as adverse events		From Day -1 to Day 9	No
Secondary	Changes in vital signs measurements		From Day -1 to Day 9	No
Secondary	Changes in concomitant therapy		From Day -1 to Day 9	No
Secondary	The number of patients with changes from baseline in clinical laboratory test results		From Day -1 to Day 9	No
Secondary	The number of patients who receive concomitant therapy		From Day -1 to Day 9	No

External Links

•   An Open-Label Study to Evaluate the Penetration of Doripenem in Cerebrospinal Fluid After Doripenem Administration in Pediatric Subjects Less Than 1 Year Chronological Age